Phase II study of gemcitabine alone in locally advanced pancreatic cancer: Japan Clinical Oncology Group Study (JCOG 0506)

UMIN ID: C000000308

Registered date:19/01/2006

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: pancreatic neoplasm
• Date of first enrollment: 2006/01/01
• Target sample size: 50
• Countries of recruitment: Japan
• Study type: Interventional
• Intervention(s): Patients receive 30-minute infusion of gemcitabine (1000 mg/m2/day, days 1, 8, and 15) every 4 weeks. It is repeated until obvious evidence of disease progression, patient refusal, or unacceptable toxicity.

Outcome(s)

• Primary Outcome: 1-year overall survival
• Secondary Outcome: clinical benefit response (CBR), CA19-9 response, adverse events

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: Not applicable
• Gender: Male and Female
• Exclude criteria: Patients are excluded if they meet the following criteria: They have obvious ascetic or pleural effusion, lung fibrosis or pneumonitis, uncontrolled diabetes mellitus in spite of using more than 40 unit insulin, Classification of New York Heart Association (NYHA) of III or IV, myocardial infarction within 6 months before this trial, synchronous or metachronous (within 5 years) malignancy other than carcinoma in situ, or severe mental disease.

Related Information

• Primary Sponsor: Japan Clinical Oncology Group(JCOG)
• Source(s) of Monetary Support: Ministry of Health, Labour and Welfare